Treatment of Post-Traumatic Stress Disorder (PTSD) and Chronic Pain After Traumatic Orthopedic Injury

NCT00957164 | Completed DMC

• 1 other identifier: STRONGSTAR*PAIN*PTSD
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to examine the efficacy of multiple treatment options in addressing the co-morbidity between pain and PTSD symptoms. Recent research has suggested that pain and PTSD co-morbidity presents unique problems for pain and PTSD treatment, and new approaches are desperately needed to address this issue. To this end, the investigators hope to identify the efficacy of a combined pain and PTSD psychosocial treatment protocol compared to that of stand-alone psychosocial treatments for pain and PTSD. The primary measure for treatment efficacy will be treatment-related changes in measures of psychosocial and functional outcomes associated with chronic pain and PTSD conditions. The investigators will additionally measure socioeconomic outcomes including return to pre-trauma job (or a job of similar capacity), maintenance of active duty work at pre-trauma capacity for 6 and/or 12 months after return, and number of healthcare appointments made between follow-ups for pain or PTSD treatment.

Conditions

Chronic Pain; Post-traumatic Stress Disorder

Keywords

Chronic pain; PTSD

Outcome Measures

Primary Outcomes (3)

• Post Traumatic Stress Disorder Symptoms/Diagnosis

  1 Year

• Chronic Pain Intensity

  1 Year

• Self-reported disability

  1 Year

Secondary Outcomes (1)

• Depression/Suicidality

  1 Year

Study Arms (4)

Pain Treatment Only

ACTIVE COMPARATOR

Pain treatment will involve five-sessions over 5 weeks of individual treatment protocol based on the existing chronic pain management program through the Clinical Health Psychology Service at Wilford Hall Medical Center. This treatment will involve covering the difference between chronic and acute pain, the role of cognitive, behavioral, and emotional variables in pain progression, and ways to manage these variables to prevent the development of chronic pain.

Behavioral: Chronic Pain Management Treatment; Behavioral: Self-Care

PTSD Treatment Only

ACTIVE COMPARATOR

The PTSD treatment used in this study is an adaptation of a brief Prolonged Exposure treatment protocol for PTSD as illustrated in a 2005 paper published by Cigrang, Peterson, and Schobitz in which a 4-session prolonged exposure treatment was used to address PTSD symptoms in three injured soldiers recently exposed to trauma. The authors found a 50+% decrease in PTSD symptoms after these four sessions. The present study will rely upon a similar brief PTSD intervention for treating chronic PTSD among trauma-exposed injured active duty service members. The PTSD intervention will be expanded into five sessions over 5 weeks to include an initial session for assessment and education on the co-morbidity of pain and PTSD. All PTSD treatment will be provided under the direct care or supervision of a Master Trained therapist in Prolonged Exposure.

Behavioral: Brief Prolonged Exposure Protocol; Behavioral: Self-Care

Combined Pain and PTSD Treatment

ACTIVE COMPARATOR

This treatment arm will involve 5 sessions each of the Pain-Only and PTSD-Only treatments described above.

Behavioral: Brief Prolonged Exposure Protocol; Behavioral: Chronic Pain Management Treatment

Treatment as Usual

NO INTERVENTION

The treatment as usual group will complete the assessments given in each of the other study arms, but will not participate in treatment through the study. Instead, participants randomized to this group will be encouraged to seek treatment for pain and/or PTSD through existing channels. Referrals for treatment will be made for those with clinically significant symptoms for pain and/or PTSD at intake.

Interventions

Brief Prolonged Exposure Protocol BEHAVIORAL

The PTSD treatment used in this study is an adaptation of a brief Prolonged Exposure treatment protocol for PTSD as illustrated in a 2005 paper published by Cigrang, Peterson, and Schobitz 54 in which a 4-session prolonged exposure treatment was used to address PTSD symptoms in three injured soldiers recently exposed to trauma. The authors found a 50+% decrease in PTSD symptoms after these four sessions. The present study will rely upon a similar brief PTSD intervention for treating chronic PTSD among trauma-exposed injured active duty service members. The PTSD intervention will be expanded into five sessions over 5 weeks to include an initial session for assessment and education on the co-morbidity of pain and PTSD. All PTSD treatment will be provided under the direct care or supervision of a Master Trained therapist in Prolonged Exposure.

Combined Pain and PTSD Treatment; PTSD Treatment Only

Chronic Pain Management Treatment BEHAVIORAL

Pain treatment will involve five-sessions over 5 weeks of individual treatment protocol based on the existing chronic pain management program through the Clinical Health Psychology Service at Wilford Hall Medical Center. This treatment will involve covering the difference between chronic and acute pain, the role of cognitive, behavioral, and emotional variables in pain progression, and ways to manage these variables to prevent the development of chronic pain.

Combined Pain and PTSD Treatment; Pain Treatment Only

Self-Care BEHAVIORAL

participants randomized to either the Pain-only or PTSD-only groups will receive five sessions of pain- or PTSD-specific treatment followed by five sessions of self-care placebo over 5 weeks. The self-care module will be manualized for reliability and fidelity between providers and will involve 60-minute sessions covering various topics.

PTSD Treatment Only; Pain Treatment Only

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 years or older
• hospital admission for any traumatic orthopedic injury defined as any musculo-skeletal injury requiring convalescence and/or surgery that is deployment related.
• Fluency in English
• Glasgow Coma Score (GCS) = 15 at time of hospital discharge
• willingness and ability to meet study follow-up requirements
• PTSD CheckList - Military (PCL-M) \> 30
• duration of any amount of pain \>12 weeks based on self-report and date of injury, and PTSD symptoms of \> to 4 weeks.
• Pain Disability Questionnaire (PDQ) \> 30
• no current need for surgical intervention for pain
• be stable on any psychotropic medications they may be taking. (Participants will be required to meet psychotropic medication stabilization criteria for the periods preceding and overlapping with the diagnostic assessment and treatment. This criterion is established in order to minimize the likelihood that significant outcome effects may be attributed to changes in psychotropic medications rather than to the treatment protocol.)
• medically cleared for study participation by Orthopedic provider or collaborating study physician
• Active Duty Military, Reserve, or Activated Reservist

You may not qualify if:

• head injury greater than mild TBI as assessed by an inability to consent to the study and complete the baseline psychological testing
• current pregnancy will exclude participation in Functional Capacity Evaluation (FCE) assessment, but not study participation. Pregnancy will be assessed by self-report
• current diagnosis of schizophrenia, bipolar disorder, or other psychotic disorder as identified by clinical interview
• primary diagnosis of burn injury, though burn patients will be eligible if burn is a secondary diagnosis and not the primary reason for pain
• participant is currently taking a benzodiazepine medication for PTSD symptoms
• unstable suicidal ideation
• currently receiving prolonged exposure treatment for PTSD

Sponsors & Collaborators

• The University of Texas at Arlington: lead
• 59th Medical Wing: collaborator
• Brooke Army Medical Center: collaborator
• The University of Texas Health Science Center at San Antonio: collaborator

Study Sites (4)

The University of Texas at Arlington

Arlington, Texas, 76019, United States

Location

Brooke Army Medical Center

Fort Sam Houston, Texas, United States

Location

Wilford Hall Medical Center

Lackland Air Force Base, Texas, 78236, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Chronic Pain; Stress Disorders, Post-Traumatic

Interventions

Self Care

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Robert J. Gatchel, Ph.D.

  University of Texas at Arlington

  PRINCIPAL INVESTIGATOR

• Donald D. McGeary, Ph.D.

  Wilford Hall Medical Center, USAF

  PRINCIPAL INVESTIGATOR

• Mysti R. Moore, MPT

  University of Texas at Arlington

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2009
• First Posted: August 12, 2009
• Study Start: August 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2013
• Last Updated: January 31, 2014

Record last verified: 2014-01

Locations

US (4)